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NICE, medtech and evidence Mrs Mirella Marlow MA MBA Programme Director MediWales 11 December 2012

NICE, medtech and evidence Mrs Mirella Marlow MA MBA Programme Director MediWales 11 December 2012. Contents. General information about NICE What do medtech products need to “prove”? How NICE works with medtech companies clarifying value propositions supporting development of evidence

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NICE, medtech and evidence Mrs Mirella Marlow MA MBA Programme Director MediWales 11 December 2012

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  1. NICE, medtech and evidence Mrs Mirella Marlow MA MBA Programme Director MediWales 11 December 2012

  2. Contents • General information about NICE • What do medtech products need to “prove”? • How NICE works with medtech companies • clarifying value propositions • supporting development of evidence • enhancing Health Technology Assessment (HTA) skills

  3. About NICE • National Institute for Health and Clinical Excellence • Established in 1999 to reduce variation in the availability and quality of NHS treatments and care • Guidance and evidence to support the health service and local authorities • Independent of government • New responsibilities from April 2013 – social care

  4. 2012 NICE products & services BRAND MAP HERE

  5. How can innovative medtech products help? (1)

  6. How can innovative medtech products help? (2)

  7. NICE works with companies Pre-evaluation • Engagement team works with companies incl. SMEs • Changing the view of the value proposition • Encouraging development of evidence • Exploring pipeline, focusing on clinical utility

  8. How does NICE identify medical technologies for evaluation? Tech Appraisals guidance (TAP) Medical technology guidance (MTEP) Diagnostics guidance (DAP)

  9. NICE value proposition options

  10. Medical technologies guidance:‘relevant’ evidence • Sponsor submission • Published and in-press trials • Unpublished data • Regulatory data • Post-market register data, audits and ‘real-life’ experience • Forthcoming trial results • Planned trials in a reasonable timeframe • Cost model • Expert advice – clinical/patient ………Must support sponsor’s claim

  11. NICE’s assessment of value • Standard clinical evidence and health economic techniques • Clinical evidence – systematic reviewing and meta-analysis, linked evidence approaches etc • Health economics – modelling, sensitivity analysis etc • World class academic assessment groups and external assessment centres • Regular review of technical methods with stakeholders • Further development of technical methods (e.g. MRC funded activities)

  12. NICE medtech recommendations

  13. Collaborating for better evidence • Pre-evaluation: • Advise companies to work with NOCRI on pipeline products • Post-evaluation: • Access to research facilitation for products with a research-only recommendation Pragmatic randomised controlled trial of MIST ultrasound therapy compared to UK standard care for the treatment of non-healing venous leg ulcers

  14. Scientific advice seminars - medtech • For developers and investors • What is meant by value from the perspective of NICE? • Know how your value proposition links to the need for specific evidence • What is meant by cost effectiveness? • Types of evidence considered by NICE • General principles of health technology assessment (HTA)

  15. Further information • NICE website: www.nice.org.uk • Contact the NICE medtech team: medtech@nice.org.uk • Apply to attend a NICE medtech seminar: adviceseminars@nice.org.uk

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